A Prospective, Randomized, Clinical Study on the Effects of CPP-ACP-paste, Fluoride and a Combination on the Evolution of White Spot Lesions in Orthodontic Patients After Debonding.

Summary

The goal of this randomized clinical trial is to compare the influence of casein phosphopeptide amorphous calcium phosphate (CPP-ACP), CPP-ACP in combination with fluoride (CPP-ACPF), high fluoride concentration, and conventional fluoride toothpaste on the color and size of white spot lesions (WSLs) in orthodontic patients following bracket removal.

Conditions

• White Spot Lesion
• Orthodontic Appliance Complication

Interventions

OTHER

CPP-ACP paste

Daily application of CPP-ACP (Casein phosphopeptide amorphous calcium phosphate) paste (Tooth Mousse®) in addition to twice daily use of conventional toothpaste.

OTHER

CPP-ACPF paste

Daily application of CPP-ACPF (Casein phosphopeptide amorphous calcium phosphate in combination with fluoridepaste) (MI Paste Plus®) in addition to twice daily use of conventional toothpaste.

OTHER

1.25% fluoride gel

Weekly application of 1.25% fluoride gel (Elmex Medical Gel®) in addition to twice daily use of conventional toothpaste.

OTHER

Conventional

Twice daily use of conventional toothpaste.

Sponsors & Collaborators

• University Hospital, Ghent

  lead OTHER

Principal Investigators

• Levine Gavel · Postgraduate Orthodontics

• Valentina Elena Arevalo Cabrera · Master Student Oral Health Sciences

• Deseyne Thomas · Alumnus Orthodontics

• Guy AM De Pauw · Professor dr. in Orthodontics

• Noëmi MC De Roo · Doctorate in Orthodontics

• Liesbeth Temmerman · dr. in Orthodontics

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-09-23

Primary Completion

2023-03-29

Completion

2023-03-29

Countries

• Belgium

Study Locations